THOUSAND OAKS, Calif., Aug. 25, 2025 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has broadened the approved use of Repatha® (evolocumab) to include adults at increased risk for major adverse cardiovascular events (MACE) due to uncontrolled low- density lipoprotein cholesterol (LDL-C), commonly known as 'bad cholesterol.' The update removes a prior requirement for a patient to have been diagnosed with cardiovascular (CV) disease. "Far too many adults a ...

Core Insights - Amgen is presenting full results from the Phase 2 study of MariTide, a peptide-antibody conjugate for obesity and Type 2 diabetes, at the 85th American Diabetes Association Scientific Sessions [1][2] - The company is also sharing new data from the Phase 3 FOURIER study of Repatha® in cardiovascular disease [1] - MariTide shows promising 52-week efficacy, safety, and tolerability data, indicating robust weight loss without a plateau in patients with obesity [3][9] Company Overview - Amgen is focused on innovative medicines for serious diseases, with a strong pipeline that includes treatments for obesity and cardiovascular conditions [20][22] - The company has been recognized as one of the "World's Most Innovative Companies" and is part of the Dow Jones Industrial Average and Nasdaq-100 Index [23] Product Information - MariTide is a bispecific GLP-1 receptor agonist and GIPR antagonist, designed to provide a dual mechanism of action for weight loss and diabetes management [9] - Repatha® is a monoclonal antibody that lowers LDL cholesterol by inhibiting PCSK9, with extensive clinical trial data supporting its efficacy [13][14] Industry Context - The prevalence of obesity has more than doubled globally from 1990 to 2022, with significant health implications including increased risk for Type 2 diabetes and cardiovascular diseases [7][8] - Despite the recognition of obesity as a chronic disease, only 1%-3% of eligible adults in the U.S. receive pharmacologic treatment for weight management [8]

Core Viewpoint - Amgen reported strong financial results for Q1 2025, with total revenues increasing by 9% year-over-year to $8.1 billion, driven by robust product sales and successful new product launches [2][5][22]. Financial Performance - Total revenues for Q1 2025 were $8.1 billion, a 9% increase compared to Q1 2024 [5]. - Product sales grew by 11%, primarily due to a 14% increase in volume, although this was partially offset by a 6% decrease in net selling price [5]. - GAAP earnings per share (EPS) were $3.20, a significant recovery from a loss of $0.21 in Q1 2024, influenced by an unrealized gain on equity investments [5]. - Non-GAAP EPS increased by 24% from $3.96 to $4.90, reflecting higher revenues despite increased operating expenses [5][18]. - Free cash flow for Q1 2025 was $1.0 billion, up from $0.5 billion in Q1 2024, attributed to improved business performance [22]. Product Sales Performance - Repatha® sales rose by 27% year-over-year to $656 million, driven by a 41% increase in volume [6]. - TEPEZZA® sales decreased by 10% year-over-year to $381 million, primarily due to lower volume and inventory levels [4]. - Fourteen products achieved double-digit sales growth, including Repatha®, BLINCYTO®, TEZSPIRE®, and EVENITY® [5]. - IMDELLTRA® generated $81 million in sales during its launch quarter, with positive Phase 3 trial results [5]. Operating Expenses and Margins - Total operating expenses increased by 8% year-over-year, with cost of sales as a percentage of product sales decreasing by 7.3 percentage points [18]. - GAAP operating income rose from $1.0 billion to $1.2 billion, with an operating margin increase of 1.1 percentage points to 15.0% [5][18]. - Non-GAAP operating income increased from $3.1 billion to $3.6 billion, with a non-GAAP operating margin of 45.7%, up 2.5 percentage points [5][18]. Guidance for 2025 - The company expects total revenues for 2025 to be in the range of $34.3 billion to $35.7 billion [23]. - GAAP EPS is projected to be between $12.21 and $13.46, while non-GAAP EPS is expected to range from $20.00 to $21.20 [23]. - Capital expenditures are anticipated to be approximately $2.3 billion for the year [23].